Specialist I/II, Regulatory Affairs

Beam Therapeutics is a biotechnology company seeking a Regulatory Specialist to participate in the preparation of documentation packages for global regulatory submissions. The ideal candidate will have a minimum BA/BS degree in a scientific/engineering discipline and 6+ years of experience in the biotech industry, preferably in Regulatory CMC or related experience.

Requirements

• Prepares documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies
• Compiles documentation for submissions to FDA and global regulatory agencies
• Develops and maintains collaborative partnerships with key internal and external stakeholders
• Participates in regulatory intelligence activities, monitors regulatory guidelines and trends, and provides regulatory advice to project teams

Benefits

• Competitive salary
• Paid Time Off
• Retirement Plan